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Supplemental new drug applications (sNDAs) were submitted to the FDA for use > espite a continual y chal enging environment, of Seroquel XR in adult patients for major including generic pressure, combined sales of Despite full generic competition to Toprol-XL depressive disorder (MDD) and generalised Arimidex, Crestor, Nexium, Seroquel and Symbicort up 5% in the US – 65% of our total US sales.
and the growth in generic omeprazole, sales anxiety disorder (GAD). In December 2008, in the US increased 1% in 2008 to $13,510 > aintained market position as the second largest brand name pharmaceutical company in Canada.
mil ion (2007: $13,366 mil ion). Combined sales from the FDA related to the MDD submission, of Arimidex, Crestor, Nexium, Seroquel, and Symbicort were up 5% to $8,803 million > trong brand performance in Western Europe but (2007: $8,414 mil ion) – 65% of our total the FDA for use of Seroquel for treatment intense competition and governmental controls US sales. AstraZeneca is currently the third of schizophrenia in 13 to 17 year olds and largest pharmaceutical company in the US, for treatment of acute manic episodes of bipolar I disorder for 10 to 17 year olds. Crestor, Losec and Seroquel in Japan.
The US Prescribing Information for Seroquel > merging Rest of World delivers strong sales Oncology and Astra Tech fell by 2% and rose and Seroquel XR is being updated to include growth, up 16% with Emerging Europe sales up 10% and Emerging Asia sales up 10%.
by 33% to $395 million (2007: $402 million) new safety information regarding use in children and $80 million (2007: $60 million), respectively.
and adolescents. Seroquel and Seroquel XR > ontinued expansion in China, including are not approved currently for use in paediatric > U Commission of a Sectoral Inquiry into the Nexium continues to lead the branded pharmaceutical industry continues, with a final proton pump inhibitor (PPI) market for new prescriptions, total prescriptions and total Crestor sales were up 18% to $1,678 million capsules dispensed. Generic pantoprazole (2007: $1,424 mil ion) with a total prescription For more information regarding our products showed strong growth after being introduced growth of 10.8%, and was the only branded please refer to the relevant sections of the statin to grow in total prescriptions throughout Therapy Area Review from page 53. Details of relevant continuing litigation can be found growth, resulting in price and share erosion in Note 25 to the Financial Statements (from across the entire branded PPI market. In the atherosclerosis in adult patients with elevated page 144) and details of relevant risks are set face of generic pressure, Nexium continued cholesterol, an important differentiator from out in the Principal Risks and Uncertainties to fare better than its branded competitors other products in the cholesterol-lowering with sales in 2008 down 8% to $3,101 mil ion market, was successfully introduced and (2007: $3,383 million). During the year, the US awareness amongst physicians is high. For the AstraZeneca definition of markets Food and Drug Administration (FDA) approved Under the terms of an agreement executed please see the Glossary on page 199.
the use of Nexium in children ages one to 11 years old for the short-term treatment of non-exclusive right to promote Crestor alongside AstraZeneca in the US (excluding Puerto Rico) increasing Crestor’s profile Seroquel maintained its strong position as and share of voice. New data presented in psychotic on the market, with sales up 5% demonstrated that Crestor 20mg significantly to $3,015 million (2007: $2,863 million). reduced major cardiovascular (CV) events – Seroquel posted total prescription growth defined by the study as the combined risk of myocardial infarction, stroke, arterial prescriptions, outpacing the rate of market revascularisation, hospitalisation for unstable growth for anti-psychotics by almost two angina, or death from CV causes – by 44% points, leading the market in absolute total prescription growth. During the year, the FDA women with elevated hsCRP (high-sensitivity approved Seroquel for the maintenance of bipolar disorder as adjunct therapy to lithium cholesterol levels. hsCRP is a recognised marker of inflammation that is associated Seroquel XR for the depressive episodes of with an increased risk of atherosclerotic CV bipolar disorder, the manic or mixed episodes events. The JUPITER results also showed associated with bipolar I disorder (as either that for patients in the trial taking Crestor, monotherapy or adjunct therapy to lithium or the combined risk of heart attack, stroke or CV divalproex), and for maintenance treatment of death was reduced by nearly half. We expect bipolar disorder as adjunct therapy to lithium to file a regulatory submission with the FDA that includes the JUPITER data in the first half of 2009 and, if approved, wil begin promotional activities within the approved labelling.
In another agreement with Abbott, we are Pulmicort Respules, the only inhaled Synagis is the only FDA-approved monoclonal investigating the fixed dose combination of corticosteroid for the treatment of asthma antibody (MAb) to help protect high-risk babies the active ingredients in Crestor (rosuvastatin approved in the US for children as young against severe Respiratory Syncytial Virus (RSV) calcium) and Trilipix™ (fenofibric acid) for the disease. In its first full year in AstraZeneca, treatment of mixed dyslipidaemia. A Phase III trial in 2008 demonstrated that a combination (2007: $964 million). On 23 September 2008, of rosuvastatin calcium and fenofibric acid the US District Court for the District of In 2008, distribution agreements continued delivers greater improvements in treating all New Jersey denied a motion filed by Teva with Par Pharmaceutical for all available three key lipids (LDL, HDL and triglycerides) Pharmaceuticals Ltd. for summary judgment strengths of generic metoprolol succinate. of no infringement in the Pulmicort Respules patent litigation. On 19 November 2008, the distribution of authorised generics of both af ects more than 100 mil ion US residents same court awarded a temporary restraining and has been shown to play a pivotal role order against Teva Pharmaceuticals after in the development of atherosclerosis and Teva launched its generic product ‘at risk’ on Currently, there is no direct government control consequently, cardiovascular disease. Patients of prices for commercial prescription drug sales with mixed dyslipidaemia are expected to the parties settled the matter and AstraZeneca in the US. However, some publicly funded granted Teva a licence to launch its generic programmes – such as Medicaid and TRICARE dyslipidaemic population. Abbott obtained (Department of Veterans Affairs) – have approval of Trilipix™ in December 2008 as statutorily mandated rebates that have the the first and only fibrate label ed for use with In its first full year after launch in June 2007, effect of price controls for these programmes. Symbicort Rapihaler (pMDI) continued to Additionally, pressure on pricing, availability deliver steady growth with sales up 410% to and utilisation of prescription drugs for both To maximise the value of Merrem IV during $255 million (2007: $50 million). Widespread physician experience and growing appreciation to increase, driven by, among other things, Cubist, who will provide promotional and of the dif erentiating feature of control plus an increased focus on generic alternatives. scientific affairs support for Merrem IV in the fast onset has led to the product surpassing Primary drivers of increased generic use are a 10% new prescription share of the inhaled budgetary policies within healthcare systems corticosteroid/long acting beta agonist market. and providers, including the use of “generics Arimidex continued to perform well with sales Symbicort is now prescribed to one in five of only” formularies, and increases in patient up 9% to $754 mil ion (2007: $694 mil ion) all patients that are new to combination therapy.
co-insurance or co-payments. While it is for the full year. Arimidex continues to be the market leader in new prescriptions for In 2008, two sNDAs were submitted to the adoption of a broad national price control FDA: one for the use of Symbicort in chronic scheme in the near term, there will continue obstructive pulmonary disease and another to be increased attention to pharmaceutical for its use in paediatric asthma for ages six to prices and their impact on healthcare costs In September 2008, an additional six-month 12. In October 2008, the pMDI device was period of exclusivity was granted to market Casodex for its licensed advanced prostate cancer indication until 1 April 2009.
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008 In the current political climate, policymakers Additional y, AstraZeneca has been providing are likely to consider healthcare reform patient assistance to the uninsured for 30 market. For patients to gain optimal access a top priority. The reauthorisation of the years and, in the last six years, has provided to medicines, they then need to be listed on State Childrens’ Health Insurance Program more than $3 bil ion in savings to more than provincial formularies. This long process means (SCHIP), a joint federal-state programme one mil ion patients in the US and Puerto patients in Canada can typically wait over to expand healthcare coverage (including two years following the regulatory approval prescription drug coverage) for qualifying than $612 million in savings to approximately children, is poised to be one of the first (approximately 2.7 million prescriptions).
The dif erent provinces have adopted dif erent the 111th Congress. A sustained focus on approaches to pharmaceutical funding, from containing prescription drug costs is also likely, which could include proposals to al ow Despite the entry of the generic forms of more open access to more restricted access, the government to negotiate Medicare Part D Seroquel IR, sales in Canada increased by therapeutic substitution and price tendering prices directly with the pharmaceutical industry, 8% (+11% reported) to $1,275 million on the horizon in British Colombia. The trend increase manufacturers’ Medicaid drug rebate (2007: $1,145 million). Combined sales of in Canada indicates provinces will increase Crestor, Nexium, Seroquel and Atacand their access restrictions and drive prices down while the complex reimbursement system will for patients who qualify for both Medicaid $713 million) with Crestor, Seroquel and continue to result in access delays.
and Medicare (so-called ‘dual eligibles’). Nexium among the top 20 prescription Additional y, there could be ef orts to pass legislation implementing comparative effectiveness research requirements and/or Sales in the rest of the world performed pharmaceutical company in Canada. Crestor importation of drugs into the US from selected maintained its number two ranking in the statin to $16,816 million (2007: $15,048 million). countries by certain individual consumers, market and was the fastest-growing product Key products (Arimidex, Crestor, Nexium, pharmacies and drug wholesalers. Finally, in both new and total prescription segments Seroquel and Symbicort) delivered a strong performance, up 14% (+20% reported) with Crestor is also the third largest product in sales of $7,413 million (2007: $6,189 million). (eg for speaker contracts) are also being Canada by sales. Together, Seroquel XR Latin America, the Middle East and Africa considered at the state and federal levels.
and Seroquel IR remain the leaders in new and Asia Pacific regions delivered particularly and total prescriptions within the atypical strong sales, up 13% (+19% reported) with In its third year of operation, the Medicare anti-psychotics market. Atacand continues sales of $5,858 million (2007: $4,906 million).
to outperform the anti-hypertensive market, maintained high levels of enrollment and with total prescription growth of over 15.0% beneficiary satisfaction, achieved prescription compared with market growth of only 7.4%. Sales in our Established Rest of World Markets volume growth similar to other mature markets Several key regulatory approvals were increased by 2% (+9% reported), with good and provided access to our medicines for growth from Crestor, Seroquel and Symbicort a large segment of the patient population. the first country in which we gained regulatory and our oncology products, together with Through the AZ&Me Prescription Savings approval for Seroquel XR for the treatment Synagis, offsetting declines in sales of our Programme for Patients with Medicare Part of bipolar mania, with Seroquel XR and proton pump inhibitors in Western Europe.
D, AstraZeneca provides prescription access Seroquel IR also approved for the treatment of to financially needy Medicare D beneficiaries. bipolar depression (approvals were received Although difficult to quantify, Medicare Part D eight months and five months respectively has had an indirect effect on pricing in the with overall growth of 1% (+7% reported). timelines). In addition, a new tablet strength This reflected decreasing sales in France chal enges, overal access in key accounts for Atacand (32mg) was approved by was maintained or improved in 2008. It is difficult to predict fully the longer-term effects reported) and Spain (down 8%, -1% reported), Organisational efficiencies were gained with the partly offset by strong growth in the UK closure of the Canadian packaging plant and (up 8%, +2% reported). Sales in established We continue to support My Medicare Matters, transfer of product packaging to the Newark, European markets were mainly impacted by a community based outreach and education Delaware facility, and further efficiencies were the loss of patent/marketing exclusivity on programme, in partnership with the National Casodex, by government initiatives to contain Council on Aging. Funding from AstraZeneca North American technology platforms.
drug expenditures and by the loss of sales due to an ageing portfolio of mature brands. These impacts were partly offset by continued organisations serving people with Medicare. a Health Technology Assessment appraisal strong performance of key products (mainly During 2007 and 2008, we supported a pilot Crestor and Seroquel).
process which rejects almost six out of 10 approaches to finding and enrolling eligible Prices Review Board has the role of setting Subsidy (LIS) programme. Over 40,000 LIS applications were submitted as a result of these demonstration projects.
Synagis sales outside the US are undertaken through a subsidiary of Abbott Laboratories agreements; interventions before national with revenue of $307 million ($169 million in 2007). We estimate that about 36% of sales Overall our sales in France were down 1% arise in Western Europe, about 32% in Japan A final report is expected in Spring 2009. and over 7% in Canada. Strong growth has $1,794 million). The strong performance of been recorded in Latin America in 2008.
with the Commission and participating in Crestor and Nexium, which gained significant market share from competitors, was offset by Most governments in Europe directly intervene Industries and Associations activities.
the loss of patent/marketing exclusivity expiry to control the price and reimbursement of prescribers in Europe has been eroded in In Japan, we were the fifth fastest-growing favour of a diverse range of payers. While the company amongst the top 15 pharmaceutical systems to control pharmaceutical spending companies, maintaining our market ranking $1,233 million), mainly due to the Casodex vary, they all have had a noticeable negative patent/marketing exclusivity expiry and the impact on the uptake and availability of growth from key products of set the biennial government restriction on access to Nexium innovative medicines. Several governments government review of downward drug prices leading to a reduction in sales of 34% over have imposed price reductions and increased to deliver sales up 4% (+18% reported) last year. Seroquel continued to grow wel with the use of generic medicines as part of to $1,957 million (2007: $1,661 million). 27% growth (+38% reported) reaching 29.5% healthcare expenditure control. Several The key drivers of growth being the continued of the market for atypical anti-psychotics.
countries are applying strict tests of cost- success of Crestor (+93%, +118% reported), effectiveness of medicines, which has reduced the continued growth of Losec (+5%, +18% In the UK, sales were up 8% (+2% reported) access of European patients to medicines in reported) and the increased penetration of to $1,020 million (2007: $1,004 million) driven areas of high unmet need. These and other Seroquel (+10%, +24% reported).
by Symbicort (+34%, +25% reported), measures al contribute to an increasingly tough Seroquel (+32%, +22% reported), and In Japan, there is formal central government Arimidex (+8%, +1% reported). Many of in Europe. However, the anticipated radical control of prices by the Ministry of Health, our other brands also performed wel with Merrem (+13%, +6% reported) being of towards direct government control of prices particular note. Competition remained intense was abandoned. Parallel trading of branded remained largely stable in the last few years. but our key brands gained market share in pharmaceuticals continues to challenge the As expected, pharmaceuticals were subject their respective segments. Especial y strong European pharmaceutical market; a report to price reductions in April 2008. The long-term were Seroquel and Symbicort achieving gains objective of the Japanese government is to of 2.4 and 1.3 percentage points respectively. acknowledged this and also highlighted raise generic volume share from 18.7% in the negative impact of paral el trading on 2007 to 30% by 2012; recent reforms have industry have entered into ‘terms of reference’ patient safety.
supported this goal by making substitution of discussions concerning potential changes a generic product for a branded product easier.
to the pricing and reimbursement scheme. In January 2008 AstraZeneca, together with The impact of these changes is likely to be several other companies, was the subject of an unannounced inspection simultaneous Asian data as part of the regulatory approval In Italy, Crestor performed strongly increasing its (Commission) of a Sectoral Inquiry (Inquiry) sales by 12% (+22% reported). The specialty into the pharmaceutical industry. The Inquiry increasing budgetary pressures associated care brands also showed good growth with relates to the introduction of innovative and Seroquel increasing sales by 19% (+28% generic medicines and covers commercial and publicly recognised the importance of the reported) with 32.9% of the market for atypical other practices, including the use of patents. pharmaceutical industry and their own drive anti-psychotics and Arimidex increasing sales On 28 November 2008 the Commission to reward innovation better in the future.
by 12% (+21% reported) with 32.0% of the published its preliminary report. The report does market for aromatase inhibitors and tamoxifen. not identify wrongdoing by any individual However, overall sales declined by 6% (+2% companies but is stated to provide a factual In Australia and New Zealand, we delivered reported) to $1,323 mil ion (2007: $1,294 basis for further consideration. The Commission a strong sales performance with sales up million) as a result of reference pricing at the has stated that it will commence individual regional level on PPIs and measures to control investigations where there are indications (2007: $715 million). Both our primary care their prescribing by physicians, combined with that competition rules have been breached. and specialist care portfolios continued Casodex patent/marketing exclusivity expiry.
The preliminary report focuses on a number to grow, driven mainly by sales growth for of issues relating to competition in the EU, Crestor, Atacand and Nexium in primary care In Spain, sales were down 8% (-1% reported) referring to strategies which the Commission and by Seroquel and Arimidex in specialist to $863 million (2007: $868 million) due to believes pharmaceutical companies use to care. On a CER basis, these five brands, Symbicort (-7%, +1% reported) and generic block or delay generic entry. Such strategies Arimidex, Crestor, Seroquel, Atacand and competition for Casodex and Arimidex.
include: patent filings and enforcement; Nexium, grew by 33% (+37% reported).
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008 In the rest of the Emerging Asia Pacific region, overall sales were up 10% (+7% reported) to $802 mil ion (2007: $749 mil ion) by achieving $3,557 million), accounting for nearly 63% strong growth in India, Indonesia, Singapore, of total sales growth outside the US. Sales in Thailand and Vietnam, where market dynamics reported) to $1,215 mil ion (2007: $1,028 million). Sales in China increased 31% (+43% reported) to $627 mil ion (2007: $437 mil ion) and sales in Emerging Asia Pacific increased 10% (+7% reported) to $802 million (2007: $1,159 million (2007: $947 million), mainly driven by Mexico, Brazil, Venezuela, Central America and the Caribbean. As a result, our As the pharmaceutical markets in Asia Pacific, market share grew to 3% in the prescription Latin America and elsewhere develop, reforms market, improving our position from tenth to in pricing and reimbursement will inevitably eighth in the prescription market ranking.
follow. As these markets become more important to our business, we have to consider This reflects the investment made to develop carefully such factors when we develop our key products in fast-growing markets. brands. In many of the major markets, such Atacand, Crestor, Nexium, Seroquel and as China, Brazil and Mexico, the patient pays Symbicort all showed strong performance directly for prescription medicines, and this with overal sales up 33% (+38% reported) to will be an increasingly important issue for our $516 million (2007: $372 million). Nexium is business. Other growing markets, such as our best sel ing prescription product in Latin direct government intervention in pricing and reported) to $185 mil ion (2007: $144 mil ion) reimbursement, more in line with the systems and the fifth best sel ing prescription product in the Latin American market. Crestor is now our second best sel ing prescription product with overal sales up 46% (+52% reported) Russia continued to enjoy strong sales growth to $128 million (2007: $84 million) and is the driven by Symbicort, Merrem and Crestor in eleventh best selling prescription product in particularly well, almost doubling its size, primarily driven by Seroquel, Nexium and Our top three largest markets in the region are Crestor. Our continued expansion included now Brazil, Mexico and Venezuela. Brazil sales were up 21% (+33% reported) to $440 mil ion (2007: $330 million), Mexico sales were up 6% (+6% reported) to $353 million (2007: $334 million) and Venezuela sales were up In China, in line with our growth and expansion 37% (+37% reported) to $142 million (2007: strategy of the past four years, we have continued to build our presence and sales (including Hong Kong) were up 31% (+43% reported) to $627 million (2007: $437 million). In 2008, the region again delivered a very We are the largest multinational pharmaceutical strong double-digit growth, driven mainly by company in the prescription market in China, Atacand, Crestor, Seroquel and Symbicort, as surveyed by the Hong Kong Association with particularly good performances in Gulf of the Pharmaceutical Industry, with a growth rate for prescription sales of 28.8% (+40.2% reported). Our investment in China increased a new marketing company in Israel as part with further growth in the number of sales of our investment plan in the region.
representatives, and continued to support our innovation discovery research centre in Shanghai and our several external collaborations, including a new clinical pharmacology unit in Peking University and a translational science laboratory in Guangdong Province People’s Hospital.

Source: http://www.astrazeneca-annualreports2010.com/2008/downloads/AZ_AR_08_DirGR.pdf


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